A Medical Device Daily

The FDA has unveiled plans to hold a three-day seminar for Israeli medical device companies in early September focused on guiding those companies through the FDA approval process.

The conference, titled "The Regulatory Pathway to Medical Device Marketing in the U.S.," will be held in Tel Aviv from Sept. 8-10 and will include the participation of numerous FDA officials as well as Israeli medical device companies and entrepreneurs.

FDA officials speaking at the recent ILSI Biomed Conference in Tel Aviv announced the meeting. Richard Kotz, acting branch chief of the FDA's Office of Surveillance and Biometrics, said, "Last summer, I met with a lot of Israeli medical device firms and it became clear to me that Israel is a major player in the medical device world. Our participation in this year's Biomed Conference [provides] the medical device community in Israel with the beginning knowledge of what is required to get devices through the FDA approval process."

The September seminar is expected to focus on issues of device classification, effectively targeting the correct patients, avoiding common pitfalls of clinical trials and examining the FDA's role in bringing medical devices to market.

"We want you to work with us to get the trial right the first time," said Dr. Herbert Lerner, deputy director in the FDA's Division of Reproductive, Abdominal and Radiological Devices. "We want to get the devices out to market, however we just need to make sure that they are safe. We still want you to talk with us when you are dealing with out-of-country trials. Come to the FDA to talk early and often this is one of the key points in moving a device into the market."

Herbert added the importance of consulting the FDA before launching a clinical trial. "When a clinical trial is needed, it's always better to do it right the first time. Work with us to get the common idea of what the trial should be. This will save money and time. We don't want to be obstacles, we just need good data."

Kotz added, "When discussing clinical trials of devices [for clearance] in the U.S., you must make sure to include a sufficient number of study sites in the U.S. and to include sufficient numbers of subjects at each site to capture within site variability. A small feasibility study will let you know if the device worked and who the intended patients should be."

South Korean distribution accord

Naviscan (San Diego), a developer of molecular breast imaging systems, said it has entered into a distribution agreement with Hae Dong Co. Ltd. to market and serve Naviscan's high-resolution, organ-specific PET scanner in South Korea.

The agreement represents the introduction of a new tool in the fight against breast cancer in South Korea. The first unit will be installed at Seoul National University Hospital, where it will be available to physicians and researchers while awaiting Korean FDA approval.

Naviscan manufactures the only commercially available Positron Emission Mammography (PEM) imaging scanner and PEM-guided biopsy system. The scanner uses PET technology to produce tomographic images that allow physicians to visualize breast tumors down to 2 mm, the width of a grain of rice.

The scanner is the size of a mammography unit and uses gentle breast immobilization, Naviscan said, "allowing for greater patient comfort, as well as reducing motion artifact and improving image resolution."

Hae Dong Co. Ltd. is a leading Korean disatributor of radiation oncology and nuclear medicine products. Naviscan said its PEM scanner is "a fitting complement to Hae Dong's molecular imaging suite of solutions."

Naviscan Chairman/CEO Paul Mirabella said, "Hae Dong is well-known and highly regarded in the molecular imaging industry and will be an ideal partner as we establish ourselves in the Korean market."

Additional distributorships have been selected in Mexico, Venezuela and Colombia. Naviscan will be launching in those countries by 4Q09, Mirabella said. "Expanding our reach globally strengthens our reputation as a leader in innovative technology, increases our company's valuation and enables breast surgeons and radiologists internationally to provide better treatment and realize better outcomes for their patients."

Ontario sets cancer research grants

The Canadian province of Ontario is taking a new step in the battle against cancer by supporting new genomics and medical research.

The provincial government is investing C$94 million to support 31 research projects and more than 300 researchers in seven communities across Ontario. More than half of the C$94 million funding will support medical research happening across the province.

Ontario Premier Dalton McGuinty said that researchers at the Ottawa Hospital Research Institute will receive C$18.5 million to help move genomics research forward and develop new treatments for cancer that would spare patients the toxic effects of chemotherapy.

The funding will also support numerous projects across the province dealing with basic science and research into information and communications technologies, clean technologies and digital media – all sectors where Ontario has significant strengths.

The life sciences sector employs 43,000 at more than 800 companies across the province, generating annual revenues of more than C$14 billion.

Ontario's Innovation Agenda is a C$3.2 billion strategy focused on making Ontario one of the best places in the world to turn new knowledge and ideas into new companies and jobs.